RT Journal Article SR Electronic T1 Analysis of Biopharmaceutical Market-Appropriate Plastic Syringe Barrel for Extractables JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 360 OP 367 VO 63 IS 4 A1 Frances Degrazio A1 Joseph Runkle A1 Jeff Smythe A1 Amy Miller YR 2009 UL http://journal.pda.org/content/63/4/360.abstract AB A study was designed to evaluate a new syringe system developed specifically for sensitive pharmaceutical and biopharmaceutical drug products. An in-depth review of the extractables portion of this program is presented and includes data generated by liquid chromatography-mass spectroscopy, gas chromatography-mass spectroscopy, ion chromatography, and inductively coupled plasma of the Crystal Zenith® barrel before and after sterilization. One leachable was identified after e-beam irradiation processing. This leachable, identified as an organic acid species, was then evaluated from a safety assessment viewpoint. The details of this program and associated results are explained in this report.